What are the responsibilities and job description for the Regulatory Affairs Engineer/Specialist position at American Orthodontics?
Duties and Responsibilities:
- Support Engineering and Product Development teams to successfully complete and obtain product registrations
- Determine the types of regulatory submissions or documentation required for projects with product design changes, manufacturing changes, or labeling changes
- Advise project teams on subjects such as pre-market regulatory requirements, export and labeling requirements, and/or clinical study requirements
- Communicate with customers and regulatory agencies to support product registrations
- Create, manage, and organize technical documentation in a document control system for domestic and international registrations
- Respond to questions from regulatory agencies and prepare additional documentation as requested
- Manage projects related to maintaining product registrations in domestic and international markets
- Support product vigilance activities through review of customer complaints, reportable incident databases, and clinical literature
- Identify relevant guidance documents, international standards, or consensus standards and ensure these are communicated through corporate policies and procedures
- Write and/or update Quality Management System procedures, standard operating procedures, and/or work instructions to align with domestic or international laws, guidelines, or standards
- Maintain current knowledge base of relevant regulations, international standards, and/or guidance documents
- Participate in internal and external audits
- Perform additional responsibilities as requested to achieve business objectives
- This position is 100% in-office in Sheboygan, WI
Qualifications:
- Bachelor’s degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or similar field from an accredited college or university desired
- Experience with medical devices or other highly regulated industries/products desired
- Experience with technical writing desired
- Demonstrated ability to lead multiple activities simultaneously
- Demonstrated thoroughness and attention to detail
- Strong written and verbal communication skills